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Thursday, 19 May 2016

Nonalcoholic Steatohepatitis (NASH), also called the ‘silent disease,’ is a kind of fatty liver disease which typically affects people that are obese or diabetic. This disease is more prevalent in the younger generation and causes liver inflammation and/or damage owing to the accumulation of fat within the liver. The exact cause of this disease is still not clear; however, research activities are underway for finding effective treatments to cure this disease.

Transparency Market Research (TMR), a market intelligence company answers some of the chief questions that may prove helpful for companies already established in the Nonalcoholic Steatohepatitis market and also for emerging companies looking to penetrate this market.

Q. Why is the treatment of NASH a prime therapeutic need?

Hepatologists have opined that NASH has emerged as a ‘ticking time bomb’ and this is why regulatory authorities such as the EMA and the FDA are supporting the requirements for the discovery of effective treatment options for curing this disease. The therapeutic needs are immense globally owing to the fact that the count of NASH cases is constantly rising, together with the obesity and diabetes epidemic. Within the U.S. alone, the prevalence of NASH is predicted to be more than 12% of the adult population.

In addition, there are a number of predictors and risk factors of NASH such as obesity, Body Mass Index (BMI), insulin sensitivity, hypertension, dyslipidemia, increase in liver enzymes, and obesity. Also, patients having NASH have an increasing risk for peripheral vascular accident or stroke and myocardial infarction.

Q. What factors will support the growth of the market for NASH therapeutics?

The rising rate of diabetes and obesity is a key factor fuelling the growth of the market. In addition, the increase in the number of clinical trials coupled with their success rate has raised the likelihood of industries receiving commercial approval for NASH therapeutics by 2017.

In addition, a number of major players are competing in the market and are conducting extensive research on therapeutics for NASH and have also received positive results from clinical trials. A recent result of a clinical trial that was conducted by Genfit satisfied the concerns of the European Medicines Agency (EMA) on the safety and efficacy of GFT505 as major therapeutics for NASH.

It was finally recommended by the EMA that the development of GFT505 as a therapeutic drug should progress to Phase III in the clinical trial. Genfit has aligned itself for registering GFT505 as the first approved therapy for NASH and this company also received a Fast Track designation on February 14, 2014 for the GFT505 NASH program.

Q. What is the flipside or biggest challenge impacting the development of the market?

The low rate of diagnosis, the low treatment seeking rates, and the low prescription rates will continue posing a major challenge in the growth of the market particularly in the developing economies. In addition, the slow advancement of therapies for NASH and the inefficiency of diagnostic tools resulting in the delayed diagnosis of NASH may also pose a negative impact on the growth of the market.